Palpitation and dizziness have also been observed with PROVENTIL HFA Inhalation Aerosol. Adverse events reported by less than 3% of the patients receiving PROVENTIL HFA Inhalation Aerosol, and by a greater proportion of PROVENTIL HFA Inhalation Aerosol patients than placebo patients, which have the potential to be related to PROVENTIL HFA Inhalation Aerosol include: dysphonia, increased sweating, dry mouth, chest pain, edema, rigors, ataxia, leg cramps, hyperkinesia, eructation, flatulence, tinnitus, diabetes mellitus, anxiety, depression, somnolence, rash.
Call your doctor at once if you have a serious side effect such as:
Some of the mothers were taking multiple medications during their pregnancies. Because no consistent pattern of defects can be discerned, a relationship between albuterol use and congenital anomalies has not been established. During worldwide marketing experience, various congenital anomalies, including cleft palate and limb defects, have been reported in the offspring of patients being treated with albuterol.
Plasma levels of albuterol sulfate and HFA-134a after inhaled therapeutic doses are very low in humans, but it is not known whether the components of PROVENTIL HFA (albuterol inhalation) Inhalation Aerosol are excreated in human milk.
PROVENTIL HFA (albuterol sulfate) Aerosol, Metered.
Do not increase the dose or frequency of doses of PROVENTIL HFA (albuterol inhalation) Inhalation Aerosol without consulting your physician. PROVENTIL HFA (albuterol inhalation) Inhalation Aerosol should not be used more frequently than recommended. While you are taking PROVENTIL HFA (albuterol inhalation) Inhalation Aerosol, other inhaled drugs and asthma medications should be taken only as directed by your physician. If you find that treatment with PROVENTIL HFA (albuterol inhalation) Inhalation Aerosol becomes less effective for symptomatic relief, your symptoms become worse, and/or you need to use the product more frequently than usual, medical attention should be sought immediay. The action of PROVENTIL HFA (albuterol inhalation) Inhalation Aerosol should last up to 4 to 6 hours.
INHALER MAY CEASE TO DELIVER MEDICATION IF NOT PROPERLY CLEANED. THE MOUTHPIECE SHOULD BE WASHED, SHAKEN TO REMOVE EXCESS WATER, AND AIR DRIED THOROUGHLY AT LEASE ONCE A WEEK. KEEPING THE PLASTIC MOUTHPIECE CLEAN IS VERY IMPORTANT TO PREVENT MEDICATION BUILD-UP AND BLOCKAGE.
In small, cumulative dose studies, tremor, nervousness, and headache appeared to be dose related. Adverse events reported in a 4-week pediatric clinical trial comparing PROVENTIL HFA Inhalation Aerosol and a CFC 11/12 propelled albuterol inhaler occurred at a low incidence rate and were similar to those seen in the adult trials.
PROVENTIL HFA Inhalation Aerosol is indicated in adults and children 4 years of age and older for the treatment or prevention of bronchospasm with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm.
If the mouthpiece should become blocked (little or no medication coming out of the mouthpiece), the blockage may be removed by washing as described above.
A study in which pregnant rats were dosed with radiolabeled albuterol sulfate demonstrated that drug-related material is transferred from the maternal circulation to the fetus.
Keep out of reach of children. Exposure to temperatures above 120°F may cause bursting. Contents under pressure. WARNING: Avoid spraying in eyes. Do not puncture or incinerate.
Albuterol sulfate is the official generic name in the United States. Albuterol sulfate is a white to off-white crystalline solid. PROVENTIL HFA Inhalation Aerosol is a pressurized metered-dose aerosol unit for oral inhalation. It contains a microcrystalline suspension of albuterol sulfate in propellant HFA-134a (1,1,1,2-tetrafluoroethane), ethanol, and oleic acid. It is soluble in water and slightly soluble in ethanol. The World Health Organization recommended name for the drug is salbutamol sulfate. The molecular weight of albuterol sulfate is 576.7, and the empirical formula is (C 13 H 21 NO 3 ) 2 •H 2 SO 4. Each actuation delivers 120 mcg albuterol sulfate, USP from the valve and 108 mcg albuterol sulfate, USP from the mouthpiece (equivalent to 90 mcg of albuterol base from the mouthpiece).
Clinically significant changes in systolic and diastolic blood pressure have been seen in individual patients and could be expected to occur in some patients after use of any beta-adrenergic bronchodilator. Albuterol sulfate, as with all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension; in patients with convulsive disorders, hyperthyroidism, or diabetes mellitus ; and in patients who are unusually responsive to sympathomimetic amines.
A reproduction study in Stride Dutch rabbits revealed cranioschisis in 7 of 19 (37%) fetuses when albuterol sulfate was administered orally at 50 mg/kg dose (approximay 680 times the maximum recommended daily inhalation dose for adults on a mg/m2 basis).
Canisters with a labeled net weight of 6.7 g contain 200 inhalations ( NDC. PROVENTIL HFA (albuterol sulfate) Inhalation Aerosol is supplied as a pressurized aluminum canister with a yellow plastic actuator and orange dust cap each in boxes of one. Each actuation delivers 120 mcg of albuterol sulfate from the valve and 108 mcg of albuterol sulfate from the mouthpiece (equivalent to 90 mcg of albuterol base).
Caution should be exercised when albuterol sulfate is administered to a nursing woman. Because of the potential for tumorigenicity shown for albuterol in animal studies and lack of experience with the use of PROVENTIL HFA (albuterol inhalation) Inhalation Aerosol by nursing mothers, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Beta-adrenergic-receptor blocking agents not only block the pulmonary effect of beta-agonists, such as PROVENTIL HFA Inhalation Aerosol, but may produce severe bronchospasm in asthmatic patients. Therefore, patients with asthma should not normally be treated with beta-blockers. In this setting, cardioselective beta-blockers should be considered, although they should be administered with caution. However, under certain circumstances, e.g., as prophylaxis after myocardial infarction, there may be no acceptable alternatives to the use of beta-adrenergic blocking agents in patients with asthma.
PROVENTIL HFA (albuterol inhalation) Inhalation Aerosol has not been studied in a geriatric population. As with other beta2-agonists, special caution should be observed when using PROVENTIL HFA (albuterol inhalation) Inhalation Aerosol in elderly patients who have concomitant cardiovascular disease that could be adversely affected by this class of drug.
SHAKE WELL BEFORE USING. Store between 15°-25°C (59°-77°F). For best results, canister should be at room temperature before use.
In an inhalation reproduction study in SPRAGUE-DAWLEY rats, the albuterol sulfate/HFA-134a formulation did not exhibit any teratogenic effects at 10.5 mg/kg (approximay 70 times the maximum recommended daily inhalation dose for adults on a mg/m2 basis).
In a 2-year study in SPRAGUE-DAWLEY rats, albuterol sulfate caused a dose-related increase in the incidence of benign leiomyomas of the mesovarium at the above dietary doses of 2 mg/kg (approximay 15 times the maximum recommended daily inhalation dose for adults on a mg/m2 basis and approximay 6 times the maximum recommended daily inhalation dose for children on a mg/m2 basis). In another study this effect was blocked by the coadministration of propranolol, a nonselective beta-adrenergic antagonist. In a 22-month study in Golden Hamsters, albuterol sulfate showed no evidence of tumorigenicity at dietary doses of up to 50 mg/kg (approximay 225 times the maximum recommended daily inhalation dose for adults on a mg/m2 basis and approximay 110 times the maximum recommended daily inhalation dose for children on a mg/m2 basis). In an 18-month study in CD-1 mice, albuterol sulfate showed no evidence of tumorigenicity at dietary doses of up to 500 mg/kg (approximay 1700 times the maximum recommended daily inhalation dose for adults on a mg/m2 basis and approximay 800 times the maximum recommended daily inhalation dose for children on a mg/m2 basis).
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Albuterol sulfate was not mutagenic in the Ames test or a mutation test in yeast. Albuterol sulfate was not clastogenic in a human peripheral lymphocyte assay or in an AH1 strain mouse micronucleus assay.
Body System/ Adverse Event (Preferred Term) PROVENTIL HFA Inhalation Aerosol (N=193) CFC 11/12 Propelled Albuterol Inhaler (N=186) HFA-134a Placebo Inhaler (N=186) Application Site Disorders Inhalation Site Sensation 6 9 2 Inhalation Taste Sensation 4 3 3 Body as a Whole Allergic Reaction/Symptoms 6 4 < 1 Back Pain 4 2 3 Fever 6 2 5 Central and Peripheral Nervous System Tremor 7 8 2 Gastrointestinal System Nausea 10 9 5 Vomiting 7 2 3 Heart Rate and Rhythm Disorder Tachycardia 7 2 < 1 Psychiatric Disorders Nervousness 7 9 3 Respiratory System Disorders Respiratory Disorder (unspecified) 6 4 5 Rhinitis 16 22 14 Upper Resp Tract Infection 21 20 18 Urinary System Disorder Urinary Tract Infection 3 4 2 *This table includes all adverse events (whether considered by the investigator drug related or unrelated to drug) which occurred at an incidence rate of at least 3.0% in the PROVENTIL HFA Inhalation Aerosol group and more frequently in the PROVENTIL HFA Inhalation Aerosol group than in the HFA-134a placebo inhaler group.
Because of the potential for beta-agonist interference with uterine contractility, use of PROVENTIL HFA (albuterol inhalation) Inhalation Aerosol for relief of bronchospesm during labor should be restricted to those patients in whom the benefits clearly outweigh the risk.
Adverse Experience Incidences (% of patients) in a Large 12-week Clinical Trial*. Adverse reaction information concerning PROVENTIL HFA Inhalation Aerosol is derived from a 12-week, double-blind, double-dummy study which compared PROVENTIL HFA Inhalation Aerosol, a CFC 11/12 propelled albuterol inhaler, and an HFA-134a placebo inhaler in 565 asthmatic patients. The following table lists the incidence of all adverse events (whether considered by the investigator drug related or unrelated to drug) from this study which occurred at a rate of 3% or greater in the PROVENTIL HFA Inhalation Aerosol treatment group and more frequently in the PROVENTIL HFA Inhalation Aerosol treatment group than in the placebo group. Overall, the incidence and nature of the adverse reactions reported for PROVENTIL HFA Inhalation Aerosol and a CFC 11/12 propelled albuterol inhaler were comparable.
The usual dosage for adults and children 4 years of age and older is two inhalations 15 to 30 minutes before exercise.
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Although the clinical significance of these effects is not known, caution is advised in the coadministration of beta-agonists with nonpotassium-sparing diuretics. The ECG changes and/or hypokalemia which may result from the administration of nonpotassium-sparing diuretics (such as loop or thiazide diuretics) can be acuy worsened by beta-agonists, especially when the recommended dose of the beta-agonist is exceeded.
If the mouthpiece becomes blocked, washing the mouthpiece will remove the blockage. If a previously effective dose regimen fails to provide the usual response, this may be a marker of destabilization of asthma and requires reevaluation of the patient and the treatment regimen, giving special consideration to the possible need for anti-inflammatory treatment, e.g., corticosteroids.
PROVENTIL HFA Inhalation Aerosol should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors or tricyclic antidepressants, or within 2 weeks of discontinuation of such agents, because the action of albuterol on the cardiovascular system may be potentiated.
PROVENTIL HFA Inhalation Aerosol does not contain chlorofluorocarbons (CFCs) as the propellant.
The active component of PROVENTIL HFA (albuterol sulfate) Inhalation Aerosol is albuterol sulfate, USP racemic α1-4-hydroxy-m-xylene-α,α'-diol sulfate (2:1)(salt), a relatively selective beta 2 -adrenergic bronchodilator having the following chemical structure:
The mouthpiece should be cleaned (with the canister removed) by running warm water through the top and bottom for 30 seconds at least once a week. The mouthpiece must be shaken to remove excess water, then air dried thoroughly (such as overnight). Blockage from medication build-up or improper medication delivery may result from failure to thoroughly air dry the mouthpiece.
It is recommended to prime the inhaler before using for the first time and in cases where the inhaler has not been used for more than 2 weeks by releasing four “test sprays” into the air, away from the face.
To maintain proper use of this product, it is important that the mouthpiece be washed and dried thoroughly at least once a week.
After such use, the mouthpiece should be rewashed and allowed to air dry thoroughly. If it is necessary to use the inhaler before it is compley dry, shake off excess water, replace canister, test spray twice away from face, and take the prescribed dose.
See illustrated Patient's Instructions for Use. SHAKE WELL BEFORE USING. Patients should be given the following information:.
Get emergency medical help if you have any of these signs of an allergic reaction : hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Distributed by: Schering Corporation, a subsidiary of Merck & Co., Inc. Rev. Developed and Manufactured by: 3M Health Care Limited, Loughborough UK or 3M Drug Delivery Systems Northridge, CA 91324, USA. 01/12. Whitehouse Station, NJ 08889, USA.
The drug did not induce cleft palate formation at a dose of 0.025 mg/kg (less than the maximum recommended daily inhalation dose for adults on a mg/m2 basis). A study in CD-1 mice given albuterol sulfate subcutaneously showed cleft palate formation in 5 of 111 (4.5%) fetuses at 0.25 mg/kg (less than the maximum recommended daily inhalation dose for adults on a mg/m2 basis) and in 10 of 108 (9.3%) fetuses at 2.5 mg/kg (approximay 8 times the maximum recommended daily inhalation dose for adults on a mg/m2 basis). Albuterol sulfate has been shown to be teratogenic in mice. Cleft palate also occurred in 22 of 72 (30.5%) fetuses from females treated subcutaneously with 2.5 mg/kg of isoproterenol (positive control).
Each canister provides 200 inhalations. This product does not contain chlorofluorocarbons (CFCs) as the propellant. It is recommended to prime the inhaler before using for the first time and in cases where the inhaler has not been used for more than 2 weeks by releasing four “test sprays” into the air, away from the face.
Large doses of intravenous albuterol have been reported to aggravate preexisting diabetes mellitus and ketoacidosis. The decrease is usually transient, not requiring supplementation. As with other beta-agonists, albuterol may produce significant hypokalemia in some patients, possibly through intracellular shunting, which has the potential to produce adverse cardiovascular effects.
The benefit:risk ratio when albuterol is administered for tocolysis has not been established. Tocolysis: Albuterol has not been approved for the management of preterm labor. Serious adverse reactions, including pulmonary edema, have been reported during the following treatment of premature labor with beta 2 -agonists, including albuterol.
(See Patient's Instructions for Use). Children should use PROVENTIL HFA (albuterol inhalation) Inhalation Aerosol under adult supervision, as instructed by the patient's physician. In general, the technique for administering PROVENTIL HFA (albuterol inhalation) Inhalation Aerosol to children is similar to that for adults.
The yellow actuator supplied with PROVENTIL HFA Inhalation Aerosol should not be used with any other product canisters, and actuator from other products should not be used with a PROVENTIL HFA Inhalation Aerosol canister. The correct amount of medication in each canister cannot be assured after 200 actuations, even though the canister is not compley empty. The canister should be discarded when the labeled number of actuations have been used.
The safety and effectiveness of PROVENTIL HFA (albuterol inhalation) Inhalation Aerosol in pediatric patients below the age of 4 years have not been established.
Effective and safe use of PROVENTIL HFA (albuterol inhalation) Inhalation Aerosol includes an understanding of the way that it should be administered. Use PROVENTIL HFA (albuterol inhalation) Inhalation Aerosol only with the actuator supplied with the product. Common adverse effects of treatment with inhaled albuterol include palpitations, chest pain, rapid heart rate, tremor, or nervousness. If you are pregnant or nursing, contact your physician about use of PROVENTIL HFA (albuterol inhalation) Inhalation Aerosol. Discard the canister after 200 sprays have been used.
In some patients, one inhalation every 4 hours may be sufficient. It is recommended to prime the inhaler before using for the first time and in cases where the inhaler has not been used for more than 2 weeks by releasing four “test sprays” into the air, away from the face. For treatment of acute episodes of bronchospasm or prevention of asthmatic symptoms, the usual dosage for adults and children 4 years of age and older is two inhalations repeated every 4 to 6 hours. More frequent administration or a larger number of inhalations is not recommended. Each actuation of PROVENTIL HFA Inhalation Aerosol delivers 108 mcg of albuterol sulfate (equivalent to 90 mcg of albuterol base) from the mouthpiece.
Mean decreases of 16% and 22% in serum digoxin levels were demonstrated after single-dose intravenous and oral administration of albuterol, respectively, to normal volunteers who had received digoxin for 10 days. The clinical significance of these findings for patients with obstructive airway disease who are receiving albuterol and digoxin on a chronic basis is unclear; nevertheless, it would be prudent to carefully evaluate the serum digoxin levels in patients who are currently receiving digoxin and albuterol.
PROVENTIL HFA (albuterol inhalation) Inhalation Aerosol should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. There are no adequate and well-controlled studies of PROVENTIL HFA Inhalation Aerosol or albuterol sulfate in pregnant women.
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Reproduction studies in rats demonstrated no evidence of impaired fertility at oral doses up to 50 mg/kg (approximay 340 times the maximum recommended daily inhalation dose for adults on a mg/m2 basis).
Keeping the plastic mouthpiece clean is very important to prevent medication buildup and blockage. The inhaler may cease to deliver medication if not properly cleaned and dried thoroughly (see PATIENT INFORMATION ). The inhaler may cease to deliver medication if not properly cleaned and air dried thoroughly.
Rare cases of urticaria, angioedema, rash, bronchospasm, and oropharyngeal edema have been reported after the use of inhaled albuterol. In addition, albuterol, like other sympathomimetic agents, can cause adverse reactions such as hypertension, angina, vertigo, central nervous system stimulation, insomnia, headache, metabolic acidosis, and drying or irritation of the oropharynx.Proventil